Recruiting
Early Phase 1

Cannabidiol Solution

Sponsor:

Mclean Hospital

Code:

NCT04075435

Conditions

Alzheimer Disease

Anxiety

Agitation,Psychomotor

Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

high CBD/low THC sublingual solution

Study Details

Brief summary:

This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).

Conditions

Alzheimer Disease

Anxiety

Agitation,Psychomotor

Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Study ID

NCT04075435

Start date

Jan 11, 2021

Status verified date

May, 2025

Completion date

Jan 16, 2026

Anticipated

Primary completion date

Jan 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI
2. MMSE score of 15-30 (inclusive)
3. Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C
4. A health care proxy available to sign consent on behalf of the participant (if applicable)
5. A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits
6. Participants and their study partner must be fluent in English
7. Must be 55-90 years old (inclusive)

Exclusion Criteria:

1. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.
2. Seizure disorder
3. Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI
4. Current episode of major depression, as determined by the MINI
5. Active substance abuse or dependence within the past 6 months, as determined by the MINI
6. Delirium (as measured by the CAM)
7. Current inpatient hospitalization
8. Current regular use of cannabinoid products (>1 use per month)
9. Positive urine screen for THC at the screening or baseline visit
10. Allergy to coconut
11. Participants taking strong inhibitors or inducers of CYP3A4 (e.g. fluconazole, fluoxetine, fluvoxamine, ticlopidine, St. John's Wort, etc.), CYP2C19 (ketoconazole, erythromycin, etc.), or anti-epileptic drugs

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: All subjects

This arm will include all subjects, individuals will administer a high CBD, low THC full spectrum sublingual solution twice daily on a variable dosing schedule.

Interventions

high CBD/low THC sublingual solution

Hemp derived solution to be administered sublingually twice daily.

Primary outcome measure

  • Total of clinician impression column on anxiety domain of the NPI-C [ Time Frame: Continuous, weeks 0-8 ]

Central Contacts and Locations

Central contacts

More Information

Sponsor

Mclean Hospital

Last update posted

May 8, 2025

Last verified

May, 2025

Keywords

  • cannabidiol
  • older adults
  • dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2025-05-08.